Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT01260324

First received: November 5, 2010

Last updated: August 17, 2011

Last verified: August 2011

History of Changes

Results First Received: March 16, 2011

Study Type:	Observational
Study Design:	Observational Model: Case Control; Time Perspective: Retrospective
Conditions:	Anterior Ischemic Optic Neuropathy Ischemic Optic Neuropathy
Intervention:	Other: No intervention given in this observational study

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

Description

NAION Cases

Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.

Controls

From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)

Participant Flow: Overall Study

	NAION Cases	Controls
STARTED	1283	20000
COMPLETED	1283	20000
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
NAION Cases	Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
Controls	From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
Total	Total of all reporting groups

Baseline Measures

	NAION Cases	Controls	Total
Number of Participants [units: participants]	1283	20000	21283
Age, Customized [units: participants]
18 to 34 years	43	5954	5997
35 to 44 years	59	4937	4996
45 to 54 years	208	4655	4863
55 to 64 years	481	3041	3522
65 to 74 years	247	902	1149
≥75 years	245	511	756
Gender [units: participants]
Female	595	10669	11264
Male	688	9331	10019
Number of participants with NAION diagnosis per calendar year ^[1] [units: participants]
Year 2003	285	3953	4238
Year 2004	236	3990	4226
Year 2005	284	4137	4421
Year 2006	231	4081	4312
Year 2007	247	3839	4086
Number of participants with NAION diagnosis per region of United States ^[1] [units: participants]
Northeast	100	2456	2556
Midwest	362	5345	5707
South	656	9158	9814
West	165	3041	3206

[1]	Medical record-adjudicated definite and possible cases and claims algorithm-derived definite and possible cases.

Outcome Measures

Hide All Outcome Measures

1. Primary:

Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age [ Time Frame: 01-January-2003 up to 31-December-2007 ]

Measure Type	Primary
Measure Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age
Measure Description	Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Age categorized by years.
Time Frame	01-January-2003 up to 31-December-2007
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Combined NAION cases and Controls populations; (n)=number of participants for NAION cases and Controls, respectively, per estimated person-years [(NAION cases n, Controls n) / person-years].

Reporting Groups

	Description
Combined NAION Cases and Controls	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis. Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).

Description

Combined NAION Cases and Controls

NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.

Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).

Measured Values

	Combined NAION Cases and Controls
Number of Participants Analyzed [units: participants]	21283
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age [units: incidence rate per 1000 person-years] Number ( 95% Confidence Interval )
Age 18 to 34 (n=43, 5,954) / 8,042,997	0.01 ( 0.00 to 0.01 )
Age 35 to 44 (n=59, 4,937) / 6,669,176	0.01 ( 0.01 to 0.01 )
Age 45 to 54 (n=208, 4,655) / 6,288,235	0.03 ( 0.03 to 0.04 )
Age 55 to 64 (n=481, 3,041) / 4,107,953	0.12 ( 0.11 to 0.13 )
Age 65 to 74 (n=247, 902) / 1,218,472	0.20 ( 0.18 to 0.23 )
Age ≥75 (n=245, 511) / 690,287	0.35 ( 0.31 to 0.40 )

Statistical Analysis 1 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.01
95% Confidence Interval	( 0.01 to 0.01 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Age 18 to 34
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.01
95% Confidence Interval	( 0.01 to 0.01 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Age 35 to 44
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.03
95% Confidence Interval	( 0.03 to 0.04 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Age 45 to 54
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.08
95% Confidence Interval	( 0.07 to 0.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Age 55 to 64
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.12
95% Confidence Interval	( 0.11 to 0.14 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Age 65 to 74
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 6 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.18
95% Confidence Interval	( 0.15 to 0.21 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Age ≥75
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 7 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.09
95% Confidence Interval	( 0.06 to 0.13 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Age 18 to 34
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 8 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.11
95% Confidence Interval	( 0.08 to 0.16 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Age 35 to 44
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 9 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.37
95% Confidence Interval	( 0.30 to 0.45 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Age 45 to 54
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 10 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	3.83
95% Confidence Interval	( 2.68 to 5.47 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Age 65 to 74
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 11 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	5.73
95% Confidence Interval	( 4.00 to 8.22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Age ≥75
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

2. Primary:

Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex [ Time Frame: 01-January-2003 up to 31-December-2007 ]

Measure Type	Primary
Measure Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex
Measure Description	Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Sex categorized as Female or Male.
Time Frame	01-January-2003 up to 31-December-2007
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].

Reporting Groups

	Description
Combined NAION Cases and Controls	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis. Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).

Description

Combined NAION Cases and Controls

Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).

Measured Values

	Combined NAION Cases and Controls
Number of Participants Analyzed [units: participants]	21283
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex [units: incidence rate per 1000 person-years] Number ( 95% Confidence Interval )
Female (n=595, 10,669) / 14,412,283	0.04 ( 0.04 to 0.04 )
Male (n=688, 9,331) / 12,604,837	0.05 ( 0.05 to 0.06 )

Statistical Analysis 1 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.04
95% Confidence Interval	( 0.04 to 0.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Female
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.05
95% Confidence Interval	( 0.05 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Male
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Sex

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.83
95% Confidence Interval	( 1.50 to 2.22 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Male
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

3. Primary:

Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year [ Time Frame: 01-January-2003 up to 31-December-2007 ]

Measure Type	Primary
Measure Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year
Measure Description	Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Calendar years include years 2003 to 2007.
Time Frame	01-January-2003 up to 31-December-2007
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].

Reporting Groups

	Description
Combined NAION Cases and Controls	NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis. Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).

Description

Combined NAION Cases and Controls

Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).

Measured Values

	Combined NAION Cases and Controls
Number of Participants Analyzed [units: participants]	21283
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year [units: incidence rate per 1000 person-years] Number ( 95% Confidence Interval )
Year 2003 (n=285, 3953) / 5,339,934	0.05 ( 0.05 to 0.06 )
Year 2004 (n=236, 3,990) / 5,389,915	0.04 ( 0.04 to 0.05 )
Year 2005 (n=284, 4,137) / 5,588,491	0.05 ( 0.05 to 0.06 )
Year 2006 (n=231, 4,081) / 5,512,843	0.04 ( 0.04 to 0.05 )
Year 2007 (n=247, 3,839) / 5,185,936	0.05 ( 0.04 to 0.05 )

Statistical Analysis 1 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.05
95% Confidence Interval	( 0.04 to 0.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Year 2003
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.05
95% Confidence Interval	( 0.04 to 0.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Year 2004
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.05
95% Confidence Interval	( 0.04 to 0.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Year 2005
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.04
95% Confidence Interval	( 0.04 to 0.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Year 2006
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.05
95% Confidence Interval	( 0.04 to 0.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Year 2007
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 6 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.77
95% Confidence Interval	( 0.61 to 0.96 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Year 2004
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 7 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.73
95% Confidence Interval	( 0.58 to 0.91 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Year 2005
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 8 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.87
95% Confidence Interval	( 0.68 to 1.12 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Year 2006
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 9 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Calendar Year

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.93
95% Confidence Interval	( 0.72 to 1.19 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Year 2007
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

4. Primary:

Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region [ Time Frame: 01-January-2003 up to 31-December-2007 ]

Measure Type	Primary
Measure Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region
Measure Description	Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Region of the United States categorized as Northeast, Midwest, South, and West.
Time Frame	01-January-2003 up to 31-December-2007
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].

Reporting Groups

Description

Combined NAION Cases and Controls

Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).

Measured Values

	Combined NAION Cases and Controls
Number of Participants Analyzed [units: participants]	21283
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region [units: incidence rate per 1000 person-years] Number ( 95% Confidence Interval )
Northeast (n=100, 2,456) / 3,317,702	0.03 ( 0.02 to 0.04 )
Midwest (n=362, 5,345) / 7,220,325	0.05 ( 0.05 to 0.06 )
South (n=656, 9,158) / 12,371,139	0.05 ( 0.05 to 0.06 )
West (n=165, 3,041) / 4,107,953	0.04 ( 0.03 to 0.05 )

Statistical Analysis 1 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.05
95% Confidence Interval	( 0.04 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Northeast
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.05
95% Confidence Interval	( 0.04 to 0.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Midwest
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.05
95% Confidence Interval	( 0.05 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate South
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.04
95% Confidence Interval	( 0.04 to 0.05 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate West
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.41
95% Confidence Interval	( 0.31 to 0.56 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Northeast
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 6 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.68
95% Confidence Interval	( 0.56 to 0.84 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Midwest
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 7 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Region

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.73
95% Confidence Interval	( 0.57 to 0.93 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio West
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

5. Primary:

Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors [ Time Frame: 01-January-2003 up to 31-December-2007 ]

Measure Type	Primary
Measure Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors
Measure Description	Person-years estimated by dividing number of Controls (20,000) by derived sampling fraction (total person-time at risk). Risk factors include diabetes, smoking, obesity, erectile dysfunction, hyperlipidemia, myocardial infarction, other coronary artery disease, congestive heart failure, hypertension, use of beta or calcium channel blockers, angiotensin-converting enzyme inhibitors, nitrates, anti-platelet agents, diuretics, and recent phosphodiesterase type 5 (PDE-5) inhibitors use. Recent use=any dispensing in the 60 days preceding date of diagnosis for NAION cases or index date for Controls.
Time Frame	01-January-2003 up to 31-December-2007
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Combined population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years]. Only the covariates selected by the step wise regression procedure were summarized.

Reporting Groups

Description

Combined NAION Cases and Controls

Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).

Measured Values

	Combined NAION Cases and Controls
Number of Participants Analyzed [units: participants]	21283
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors [units: incidence rate per 1000 person-years] Number ( 95% Confidence Interval )
Diabetes (n=349, 1,131) / 1,527,818	0.23 ( 0.21 to 0.25 )
Smoking (n=48, 232) / 313,399	0.15 ( 0.11 to 0.20 )
Obesity (n=25, 273) / 368,784	0.07 ( 0.04 to 0.10 )
Nitrates (n=71, 171) / 230,996	0.31 ( 0.24 to 0.39 )
Anti-platelet agents (n=127, 182) / 245,856	0.52 ( 0.43 to 0.61 )
Diuretics (n=134, 296) / 399,853	0.34 ( 0.28 to 0.40 )
Recent PDE-5 inhibitors use (n=17, 202) / 272,873	0.06 ( 0.04 to 0.10 )

Statistical Analysis 1 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.09
95% Confidence Interval	( 0.08 to 0.10 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Diabetes
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.11
95% Confidence Interval	( 0.08 to 0.14 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Smoking
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.04
95% Confidence Interval	( 0.03 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Obesity
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.07
95% Confidence Interval	( 0.06 to 0.09 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Nitrates
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.15
95% Confidence Interval	( 0.12 to 0.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Anti-platelet agents
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 6 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.13
95% Confidence Interval	( 0.09 to 0.17 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Diuretics
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 7 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.03
95% Confidence Interval	( 0.01 to 0.04 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Recent PDE-5 inhibitors use
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 8 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.82
95% Confidence Interval	( 1.47 to 2.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Diabetes
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 9 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.34
95% Confidence Interval	( 0.63 to 2.85 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Smoking
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 10 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.43
95% Confidence Interval	( 0.23 to 0.81 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Obesity
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 11 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.63
95% Confidence Interval	( 0.42 to 0.94 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Nitrates
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 12 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	2.12
95% Confidence Interval	( 1.53 to 2.94 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Anti-platelet agents
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 13 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	2.24
95% Confidence Interval	( 1.46 to 3.43 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Diuretics
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 14 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Baseline Risk Factors

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	0.57
95% Confidence Interval	( 0.31 to 1.04 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Recent PDE-5 inhibitors use
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

6. Primary:

Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses [ Time Frame: 01-January-2003 up to 31-December-2007 ]

Measure Type	Primary
Measure Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses
Measure Description	Person-years estimated by dividing the number of Controls participants by the derived sampling fraction (20,000 divided by the total person-time at risk). Comorbid diagnoses categorized according to the International Classification of Diseases ninth-edition (ICD-9) diagnoses. Categories include Occlusion and stenosis of precerebral arteries (Occlusion / Stenosis), Other disorders of bone and cartilage (Bone and Cartilage), Symptoms involving head and neck (Head and Neck), and Other ill defined and unknown causes of morbidity and mortality (Ill defined / Unknown causes).
Time Frame	01-January-2003 up to 31-December-2007
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Combined population includes NAION cases and Controls population; (n)=number of participants for NAION cases and Controls, respectively, and estimated person-years [(n=NAION cases, Controls) / person-years].

Reporting Groups

Description

Combined NAION Cases and Controls

Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).

Measured Values

	Combined NAION Cases and Controls
Number of Participants Analyzed [units: participants]	21283
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses [units: incidence rate per 1000 person-years] Number ( 95% Confidence Interval )
Other retinal disorders (n=337, 240) / 324,205	1.04 ( 0.93 to 1.16 )
Glaucoma (n=161, 353) / 476,852	0.34 ( 0.29 to 0.39 )
Cataract (n=245, 405) / 547,097	0.45 ( 0.39 to 0.51 )
Visual disturbances (n=291, 130) / 175,611	1.66 ( 1.47 to 1.86 )
Blindness and low vision (n=103, 11) / 14,859	6.93 ( 5.66 to 8.41 )
Other disorders of eye (n=143, 201) / 271,522	0.53 ( 0.44 to 0.62 )
Occlusion / Stenosis (n=98, 75) / 101,314	0.97 ( 0.79 to 1.18 )
Acute sinusitis (n=92, 1,123) / 1,517,011	0.06 ( 0.05 to 0.07 )
Other dermatoses (n=114, 536) / 724,059	0.16 ( 0.13 to 0.19 )
Bone and cartilage (n=114, 504) / 680,831	0.17 ( 0.14 to 0.20 )
Head and neck (n=181, 771) / 1,041,510	0.17 ( 0.15 to 0.20 )
Ill defined / Unknown causes (n=71, 183) / 247,207	0.29 ( 0.22 to 0.36 )

Statistical Analysis 1 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.33
95% Confidence Interval	( 0.28 to 0.39 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Other retinal disorders
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.13
95% Confidence Interval	( 0.11 to 0.16 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Glaucoma
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.20
95% Confidence Interval	( 0.08 to 0.41 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Cataract
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.99
95% Confidence Interval	( 0.83 to 1.17 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Visual disturbances
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	2.00
95% Confidence Interval	( 1.60 to 2.46 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Blindness and low vision
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 6 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.19
95% Confidence Interval	( 0.16 to 0.23 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Other disorders of eye
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 7 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.22
95% Confidence Interval	( 0.18 to 0.27 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Occlusion and stenosis of precerebral arteries
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 8 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.07
95% Confidence Interval	( 0.05 to 0.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Acute sinusitis
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 9 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.06
95% Confidence Interval	( 0.05 to 0.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Other dermatoses
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 10 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.08
95% Confidence Interval	( 0.06 to 0.10 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Other disorders of bone and cartilage
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 11 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.12
95% Confidence Interval	( 0.10 to 0.14 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Symptoms involving head and neck
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 12 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.14
95% Confidence Interval	( 0.10 to 0.18 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Other ill defined and unknown causes of morbidity and mortality
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability of having NAION predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 13 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	6.65
95% Confidence Interval	( 4.72 to 9.38 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Other retinal disorders
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 14 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	2.60
95% Confidence Interval	( 1.77 to 3.81 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Glaucoma
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 15 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.31
95% Confidence Interval	( 1.02 to 1.68 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Cataract
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 16 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	14.20
95% Confidence Interval	( 10.40 to 19.30 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Visual disturbances
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 17 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	15.10
95% Confidence Interval	( 6.60 to 34.50 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Blindness and low vision
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 18 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	2.02
95% Confidence Interval	( 1.44 to 2.82 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Other disorders of eye
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 19 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.22
95% Confidence Interval	( 0.64 to 2.31 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Occlusion and stenosis of precerebral arteries
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 20 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.29
95% Confidence Interval	( 0.96 to 1.74 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Acute sinusitis
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 21 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.34
95% Confidence Interval	( 1.02 to 1.77 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Other dermatoses
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 22 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.32
95% Confidence Interval	( 0.98 to 1.77 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Other disorders of bone and cartilage
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 23 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.37
95% Confidence Interval	( 1.02 to 1.84 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Symptoms involving head and neck
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

Statistical Analysis 24 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Comorbid Diagnoses

Groups ^[1]	Combined NAION Cases and Controls
Odds Ratio (OR) ^[2]	1.64
95% Confidence Interval	( 1.08 to 2.49 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Odds ratio Ill defined and unknown causes of morbidity and mortality
[2]	Other relevant estimation information:
	Odds ratio derived from covariate-adjusted logisitic regression model and adjusted for all other covariates in the table.

7. Primary:

Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use [ Time Frame: 01-January-2003 up to 31-December-2007 ]

Measure Type	Primary
Measure Title	Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use
Measure Description	Person-years estimated by dividing the number of Controls by the derived sampling fraction (20,000 divided by total person-time at risk). PDE-5 inhibitor use categorized by frequency of use in the number of days specific preceding diagnosis for NAION Cases or preceding the index date for Controls: Recent use=any dispensing in the preceding 60 days; Any use=any PDE-5 inhibitors use; Chronic use=at least a total of 26 days supply or 5 dispensings in the preceding 183 days; Non-chronic use=any dispensing in the preceding 183 days that does not meet the criteria for chronic use; Never use=none.
Time Frame	01-January-2003 up to 31-December-2007
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Combined NAION cases and Controls populations. N=number of participants according to frequency of PDE-5 inhibitor use for males 40 years or older; (n)=number of participants for NAION cases and Controls, respectively, per variable of frequency of use and estimated person-years [(n=NAION cases, Controls) / person-years].

Reporting Groups

Description

Combined NAION Cases and Controls

Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000).

Measured Values

	Combined NAION Cases and Controls
Number of Participants Analyzed [units: participants]	6219
Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use [units: incidence rate per 1000 person-years] Number ( 95% Confidence Interval )
Recent use (n=17, 187) / 254,239	0.05 ( 0.03 to 0.09 )
Any use (n=32, 322) / 437,780	0.06 ( 0.04 to 0.09 )
Chronic use (n=16, 162) / 220,249	0.06 ( 0.03 to 0.10 )
Non-chronic use (n=16, 160) / 217,530	0.07 ( 0.04 to 0.11 )
Never use (n=631, 5,234) / 7,115,962	0.09 ( 0.08 to 0.10 )

Statistical Analysis 1 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.05
95% Confidence Interval	( 0.03 to 0.07 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Recent use
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 2 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.06
95% Confidence Interval	( 0.04 to 0.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Any use (includes chronic and non-chronic use)
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 3 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.05
95% Confidence Interval	( 0.03 to 0.08 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Chronic use
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 4 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.06
95% Confidence Interval	( 0.03 to 0.11 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Non-chronic use
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.

Statistical Analysis 5 for Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by PDE-5 Inhibitor Use

Groups ^[1]	Combined NAION Cases and Controls
Incidence rate per 1000 person-years ^[2]	0.09
95% Confidence Interval	( 0.08 to 0.10 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Incidence rate Never use
[2]	Other relevant estimation information:
	Standardized to the quintiles of the probability predicted by all the other risk factors of NAION among the Controls.

8. Primary:

Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review) [ Time Frame: 01-January-2003 up to 31-December-2007 ]

Measure Type	Primary
Measure Title	Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)
Measure Description	No text entered.
Time Frame	01-January-2003 up to 31-December-2007
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants from the NAION cases population adjudicated by medical record review.

Reporting Groups

Description

NAION Cases

NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.

Measured Values

	NAION Cases
Number of Participants Analyzed [units: participants]	74
Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review) [units: participants]
Acute	35
Intermittent	3
Chronic	1
Unknown	35

No statistical analysis provided for Number of Participants With NAION by Time Course of Visual Change Onset: Intermittent, Abrupt (Acute), or Chronic (Adjudicated by Medical Record Review)

9. Primary:

Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [ Time Frame: 01-January-2003 up to 31-December-2007 ]

Measure Type	Primary
Measure Title	Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Measure Description	Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.
Time Frame	01-January-2003 up to 31-December-2007
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with resolution of visual symptoms (each set of variables); (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].

Reporting Groups

Description

NAION Cases

NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.

Measured Values

	NAION Cases
Number of Participants Analyzed [units: participants]	57
Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [units: incidence rate ratio] Number ( 95% Confidence Interval )
Age 18 to 64 years (n=18) / 25.53	1.00 ( NA to NA ) ^[1]
Age ≥65 years (n=9) / 29.94	0.56 ( 0.25 to 1.25 )
Female (n=14) / 31.69	1.00 ( NA to NA ) ^[1]
Male (n=13) / 23.77	1.22 ( 0.57 to 2.62 )

[1]	Result value is the reference category for calculation of the rate ratio; CI not applicable.

No statistical analysis provided for Incidence Rate Ratio Between NAION Risk Factors and Resolution of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

10. Primary:

Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [ Time Frame: 01-January-2003 up to 31-December-2007 ]

Measure Type	Primary
Measure Title	Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Measure Description	Categorized by risk factors of age (years) and sex (male or female). Incidence rate ratio and the 95% confidence interval adjusted for all the other covariates in the table.
Time Frame	01-January-2003 up to 31-December-2007
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participant population with definite and possible NAION cases identified by medical record review. N=number of participants with recurrence of visual symptoms; (n)=number of participants for variable (age or sex) for NAION cases and estimated person-years [(n=NAION cases) / person-years].

Reporting Groups

Description

NAION Cases

NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.

Measured Values

	NAION Cases
Number of Participants Analyzed [units: participants]	74
Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) [units: incidence rate ratio] Number ( 95% Confidence Interval )
Age 18 to 64 years (n=2) / 66.63	1.00 ( NA to NA ) ^[1]
Age ≥65 years (n=1) / 57.39	0.62 ( 0.06 to 6.96 )
Female (n=1) / 66.05	1.00 ( NA to NA ) ^[1]
Male (n=2) / 57.97	2.03 ( 0.18 to 22.70 )

[1]	Result value is the reference category for calculation of the rate ratio; CI not applicable.

No statistical analysis provided for Incidence Rate Ratio Between NAION Risk Factors and Recurrence of Visual Symptoms of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)

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Other Adverse Events

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01260324 History of Changes
Other Study ID Numbers:	A1481282
Study First Received:	November 5, 2010
Results First Received:	March 16, 2011
Last Updated:	August 17, 2011
Health Authority:	United States: Institutional Review Board

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